Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Status Completed

Clinical Trial Summary

The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

Clinical Trial Description

Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data.

No vaccine products will be provided or administered as part of this registry protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01945424
Study type	Observational [Patient Registry]
Source	Sanofi
Contact
Status	Completed
Phase
Start date	August 16, 2013
Completion date	September 15, 2019

View Details

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